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Megadyne 1350

by Megadyne Medical Products, Inc.

Megadyne 1350 is a Class II device made by Megadyne Medical Products, Inc., cleared under FDA 510(k) K050579 on 24 Mar 2005 and listed in FDA GUDID since 4 Sep 2018 (UDI-DI 10614559102893), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K050579

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10614559102893 UDI-DI Date4 Sep 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050579 Date24 Mar 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050579 decided 24 Mar 2005 Active
  • FDA GUDID UDI-DI 10614559102893 listed 4 Sep 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-2792-2018 FDA Class II initiated 15 May 2018

    If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.

Timeline

3 dated events

  1. Cleared FDA 510(k) K050579
  2. Recall initiated FDA recalls Z-2792-2018
  3. Listed FDA GUDID 10614559102893

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Megadyne
Generic name
Electrosurgical system generator
Model / reference
1350
Primary DI / UDI-DI
10614559102893
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical system generator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K050579)

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, cutting & coagulation & accessories).

Other devices from Megadyne Medical Products, Inc.

See all devices from Megadyne Medical Products, Inc. →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)